Functional Constipation in ChildrenNCT02193997
Constipation Fiber Trial
A study testing Fiber in people with Functional Constipation in Children, run by Warren Bishop at 1 site in United States.
Trial summary
This study examines the effects of dietary fiber in the treatment of functional childhood constipation. Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation in Children
- What is being tested?
- Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-16 years of age with functional constipation as defined based on the Rome III criteria
Who cannot join
- Constipation attributable to organic and anatomic causes or intake of medication
- Children who had previous surgery of the colon or anus
- History of allergy/intolerance to components of snack bar (e.g. celiac disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation
This study examines the effects of dietary fiber in the treatment of functional childhood constipation.
Read the detailed description
This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary fiber in treating functional childhood constipation. The addition of fiber is anticipated to allow children to have more normal stool consistency and frequency.
All participants will be asked to take a snack bar twice daily and will be randomized in a 1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked to take low-dose Miralax to avoid worsening of constipation in all groups.
- Conditions
- Functional Constipation in Children
- Being tested
- Fiber, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberOther
Also called Single fiber type
FiberOther
Also called Blend of fiber types
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Fiber 1 | Experimental | Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks Receives: Other: Fiber |
| Fiber 2 | Experimental | Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks Receives: Other: Fiber |
| Placebo | Placebo comparator | Bar with low fiber content (placebo) once daily for 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stool frequency
Measured: 4 weeks
Change in stool consistency
Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warren Bishop
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Warren Bishop, University of Iowa
- Investigators
- Warren Bishop, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193997
- Sponsor's protocol ID
- 201203734
- Status last verified
- Sep 2017
- First submitted
- 24 Jun 2014
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation
- ClinicalTrials.gov ID
- NCT02193997
- Acronym / sponsor ID
- 201203734
- Conditions
- Functional Constipation in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Warren BishopUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effects of dietary fiber in the treatment of functional childhood constipation.
Detailed description
This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary fiber in treating functional childhood constipation. The addition of fiber is anticipated to allow children to have more normal stool consistency and frequency.
All participants will be asked to take a snack bar twice daily and will be randomized in a 1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked to take low-dose Miralax to avoid worsening of constipation in all groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fiber 1 | Experimental | Other: FiberFiber bar containing inulin as fiber soucre taken once daily for 4 weeks |
| Fiber 2 | Experimental | Other: FiberFiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks |
| Placebo | Placebo comparator | Other: PlaceboBar with low fiber content (placebo) once daily for 4 weeks |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 2-16 years of age with functional constipation as defined based on the Rome III criteria
Key exclusion criteria (3 listed)
- Constipation attributable to organic and anatomic causes or intake of medication
- Children who had previous surgery of the colon or anus
- History of allergy/intolerance to components of snack bar (e.g. celiac disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiberAlso: Single fiber type | Other | Fiber 1 |
| FiberAlso: Blend of fiber types | Other | Fiber 2 |
| Placebo | Other | Placebo |
Primary outcome
Change in stool frequency
Time frame: 4 weeks
Change in stool consistency
Time frame: 4 weeks
Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Bishop, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber in people with Functional Constipation in Children, run by Warren Bishop at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool frequency (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.